MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 25G X 5/8IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE; SYRINGE AND NEEDLE

Catalog Number 305780

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Abrasion (1689)

Event Date 11/05/2015

Event Type  Injury  

Manufacturer Narrative

Result: a sample was not returned for evaluation.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5020349.Conclusion: as there was no actual returned sample for evaluation, an absolute root cause for this incident cannot be determined.

Event Description

It was reported that the device's pink safety cap broke off and the nurse either scraped herself with either the safety shield or the needle.The nurse followed the hospital needle stick injury protocol.

Manufacturer Narrative

The clinician who received a needle stick is a licensed practical nurse.It was reported that the nurse followed the needle stick protocol, which entails assessment by the emergency department and receiving "the needlestick/exposure package.The source patient was not known to have an infectious disease.

Manufacturer Narrative

Capa #(b)(4) was omitted from the investigation results on the initial mdr.This capa is to identify and address the potential causes of safety shield disengagement.

• Brand Name: 25G X 5/8IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5250607
• MDR Text Key: 32143823
• Report Number: 8041187-2015-00017
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K010188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 305780
• Device Lot Number: 5020349
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention